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Validation of in vitro test method for chemicals endocrine disrupting potential

RISE participates in a European validation project regarding in vitro test methods that assess the endocrine disrupting potential of chemicals. The methods can ideally be used for regulatory safety assessment, thus reducing negative human health and environmental impacts caused by endocrine disruptors and reducing the use of laboratoratory animals.

Aim and goal

The EU has been working for many years to replace animal testing with animal-free (i.e. in vitro) test methods, and to limit human and animal exposure to endocrine disruptors, which are suspected of both affecting reproduction and being carcinogenic. This project aims to further develop and to validate in vitro test methods that can assess the endocrine disrupting potential of chemicals.

Challenge

To assess a chemical, one must first identify if it has endocrine disrupting potential, and if so, which type. For the assessment to be reliable, the test method must be validated. A validation involves a comprehensive evaluation of the method to determine its reliability and relevance for the intended purpose.

Solution

With our extensive experience in both in vitro methods and the quality requirements for methods aimed for regulatory purposes, we are now participating in our second major validation study organized by EURL ECVAM, the EU reference laboratory for alternatives to animal testing. The study aims to further develop and then validate in vitro methods for the detection of chemicals which disrupt thyroid function. This work largely involves generation of quality assured (GLP) experimental data and documentation. We have previously successfully participated in a similar validation study for a test method concerning androgen disrupting properties.

Effect

Following successful validation, the method is expected to be included in the OECD guidelines for the testing of chemicals, thereby obtaining both global impact and application for regulatory safety assessment. Thus, the project can contribute to reducing human and animal exposure to endocrine disruptors and to reducing the use of experimental animals.


Summary

Project name

Validation of an in vitro test method

Status

Active

RISE role in project

RISE has been selected by EURL ECVAM to assess one out of 17 methods with the potential to detect thyroid disrupting chemicals. RISE is responsible for further developing and finalizing the method (part 1) and as a first lab validating the method (part 2)

Project start

Duration

Part 1: 2018-2020, Part 2: 2021-2022

Total budget

5.3 MSEK for Part 1 (Definition of the method)

Partner

EURL ECVAM

Funders

FORMAS

The UN sustainable development goals

3. Good health and well-being
12. Responsible consumption and production

Coordinators

Project members

External press

Emma Pedersen

Contact person

Emma Pedersen

Forskare

+46 10 516 54 52
emma.pedersen@ri.se

Read more about Emma